Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
Phoenix WinNonlin Va.. - Pharsight Corporation
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How Do I Perform Computer System <strong>Va</strong>lidation?<br />
The FDA offers a guidance document (a document which describes<br />
the FDA’s current thinking on a topic, but which is not law).<br />
General Principles of Software <strong>Va</strong>lidation; Final Guidance for Industry and FDA<br />
Staff, Issued 11 January 2002 by the FDA Center for Devices and Radiological<br />
Health: Applicable to the validation of medical device software or the validation<br />
of software used to design, develop, or manufacture medical devices. Based on<br />
generally recognized software validation principles and, therefore, can be applied<br />
to any software. No final guidance documents issued by CDER or CBER.<br />
Outlines a <strong>Va</strong>lidation Life Cycle similar to a Software Development Life Cycle:<br />
“[Customers] should develop a validation life cycle model that is appropriate for<br />
their computer systems and organization.” <strong>Va</strong>lidation activities will be governed<br />
by a customer’s Corporate Quality System Policy, Corporate <strong>Va</strong>lidation Policy,<br />
System Implementation Policy, etc.